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KETRON® PEEK-CLASSIX LSG

KETRON PEEK-CLASSIX LSG white stock shapes are produced from Invibio PEEK-CLASSIX White resin. This material exhibits a unique combination of mechanical properties, temperature and chemical resistance. The composition of the Invibio PEEK-CLASSIX White resin complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. KETRON PEEK-CLASSIX LSG stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make KETRON PEEK-CLASSIX LSG stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets. Physical properties (indicative values g)

PROPERTIES Colour Density Water absorption: - after 24 / 96h immersion in water of 23°C (1) - at saturation in air of 23°C / 50% RH - at saturation in water of 23°C Thermal properties Melting temperature (DSC, 10°C/min) Thermal conductivity at 23°C Coefficient of linear thermal expansion: - average value between 23 and 100°C - average value between 23 and 150°C - average value above 150°C Temperature of deflection under load: - method A: 1.8 MPa Max. allowable service temperature in air: - for short periods (2) - continuously: for min. 20,000 h (3) Min. service temperature (4) Flammability (5): - "Oxygen index" - according to UL 94 (1.5 / 3 mm thickness) Mecanical Properties at 23°C (6) Tension test (7): - tensile stress at yield (8) - tensile strength (8) - tensile strain at yield (8) - tensile strain at break (8) - tensile modulus of elasticity (9) Compression test (10): - compressive stress at 1 / 2 / 5% nominal strain (9) Flexural test (11) (12): - flexural strength - flexural strain at flexural strength - flexural stress at conventional deflection Charpy impact strength ­ unnotched (13) Charpy impact strength ­ notched Ball indentation hardness (14) Rockwell hardness (14) Electrical Properties at 23 °C Volume resistivity Test methods ISO / (IEC) 1183 62 62 11357 75 4589 Units g/cm³ mg % % % °C W/(K.m) m/(m.K) m/(m.K) m/(m.K) °C °C °C °C % VALUES white 1.39 4/9 0.05 / 0.10 0.20 0.45 340 0.25 50.10-6 55.10-6 130.10-6 165 310 250 - 50 35 V-0 / V-0 (5)

Legend:

® ®

(1) (2) (3)

(4)

527 527 527 527 527 604 178 178 178 179-1/1eU 179-1/1eA 2039-1 2039-2 (60093)

MPa MPa % % MPa MPa MPa % MPa kJ/m² kJ/m² MPa Ohm.cm Ohm

115 115 4.5 14 4,600 40 / 79 / 143 175 6 140 400 3.5 190 M 105 > 1014 > 1013

(6)

(7) (8) (9) (10) (11) (12) (13) (14)

g

According to method 1 of ISO 62 and done on discs 50 x 3 mm. Only for short time exposure (a few hours) in applications where no or only a very low load is applied to the material. Temperature resistance over a period of min. 20,000 hours. After this period of time, there is a decrease in tensile strength of about 50% as compared with the original value. The temperature value given here is thus based on the thermal-oxidative degradation which takes place and causes a reduction in properties. Note, however, that the maximum allowable service temperature depends in many cases essentially on the duration and the magnitude of the mechanical stresses to which the material is subjected. Impact strength decreasing with decreasing temperature, the minimum allowable service temperature is practically mainly determined by the extent to which the material is subjected to impact. The value given here is based on unfavourable impact conditions and may consequently not be considered as being the absolute practical limit. These ratings - derived from raw material supplier data and other publications - are not intended to reflect hazards presented by the materials under actual fire conditions. There is no UL-yellow card available for KETRON PEEK-CLASSIX LSG white stock shapes. The figures given for the mechanical properties are average values of tests run on test specimens machined out of rod Ø 50 mm. Unless otherwise specified, the test specimens were taken from the mid between center and outside diameter with their largest size taken in axial direction (parallel to the extrusion direction). Test specimens: Type 1 B Test speed: 50 mm/min (chosen acc. to ISO 10350-1 as a function of the ductile behaviour of the material) Test speed: 1 mm/min Test specimens: cylinders 8 x 16 mm Test specimens: bars 4 x 10 x 80 mm Test speed: 2 mm/min Pendulum used: 25 J Measured on 10 mm thick disks Ø 50 mm, mid between center and outside diameter. © 2005 Copyright Quadrant AG ­ Issue date: December 1, 2005 This table is a valuable help in the choice of a material. The data listed here fall within the normal range of product properties. However, they are not guaranteed and they should not be used to establish material specification limits nor used alone as the basis of design.

PRODUCT

Surface resistivity (60093) Note: 1 g/cm³ = 1,000 kg/m³ ; 1 MPa = 1 N/mm² ; 1 kV/mm = 1 MV/m

Certifications on biocompatibility type testing USP Class VI ; ISO 10993-4 (hemocompatibility) ; ISO 10993-5 (cytotoxicity) ; ISO 10993-10 (intracutaneous reactivity & sensitization) ; ISO 10993-11 (acute systemic toxicity)

Quadrant's Life Science Grades should not be used for applications involving medical devices that are intended to remain implanted in the human body continuously for a period exceeding 24 hours/30 days*, or are intended to remain in contact with internal human tissue or bodily fluids for more than 24 hours/30 days*, or as critical components of medical devices that are essential to the continuation of human life. ® *: the period of 30 days only applies to KETRON PEEK-CLASSIX LSG white.

KETRON® is a registered trademark of Quadrant AG. Invibio® is a registered trademark of Invibio Ltd. and PEEK-CLASSIX is a trademark of Invibio Ltd.

All information supplied by or on behalf of Quadrant Engineering Plastic Products in relation to its products, in any form, is supported by research and believed to be reliable, but Quadrant Engineering Plastic Products assumes no liability whatsoever in respect of application, processing or use made of the aforementioned information or products, or any consequence thereof. The buyer undertakes all liability in respect of the application, processing or use of the aforementioned information or product, whose quality and other properties he shall verify, or any consequence thereof. No liability whatsoever shall attach to Quadrant Engineering Plastic Products for any infringement of the rights owned or controlled by a third party in intellectual, industrial or other property by reason of the application, processing or use of the aforementioned information or products by the buyer.

Quadrant Engineering Plastic Products

global leader in engineering plastics for machining www.quadrantplastics.com

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Microsoft Word - KETRON_PEEK_CLASSIX_LSG_15112005.doc